Jeff Evans

HOT SPRINGS, VA. — Greater use of air bag restraints in motor vehicle accidents may not only save lives and reduce the rates of most injuries and infectious complications, but also save trauma centers millions of dollars, according to a review of patients treated at a trauma center over an 11-year period.

Air bags were found to reduce injuries to all parts of the body except the extremities. If all unrestrained patients admitted to the trauma center had used seat belts and air bags, more than $14 million would have been saved in costs of treating infections, as well as almost $50 million in ICU stays.

Since the National Highway Transportation and Safety Administration mandated airbags for the front driver's side in 1989 and the front passenger side in 1998, “there has been a fair amount of controversy that's developed about their safety,” Dr. Timothy C. Fabian reported at the annual meeting of the Southern Surgical Association.

While most studies of motor vehicle accidents at the scene of the accident have found significantly lower odds of death with the use of seat belts alone or seat belts combined with air bags, some studies have shown only very modest or no benefit from air bags alone.

“All these studies are basically analyses of accidents at the scene. What we chose to do was look at patients admitted to a level I trauma center to see outcomes on those individuals,” said Dr. Fabian, chairman of the surgery department at the University of Tennessee Health Science Center, Memphis.

“It's sort of closing the loop to some degree … compared to previous studies,” said Dr. Fabian, who also is one of the founders of the Elvis Presley Memorial Trauma Center at the Regional Medical Center at Memphis.

In a study of 14,390 victims of motor vehicle accidents who were taken to the Presley Memorial Trauma Center during 1996–2006, investigators divided the patients into those who were unrestrained (7,881), used an air bag alone (692), used a seat belt alone (4,909), or used both seat belt and air bag (908).

Compared with unrestrained patients, injuries to several body regions (brain, face, cervical spine, and chest), but not the extremities, significantly decreased with the use of an air bag alone, a seat belt alone, or a seat belt and air bag combined. Injuries to the extremities significantly increased with the use of an air bag alone or in conjunction with a seat belt, but not with a seat belt alone. Abdominal injuries declined significantly only with use of an air bag alone or in combination with a seat belt.

Hospital mortality, as well as number of days in the ICU and hospital, declined significantly as the level of restraint increased.

The age of drivers and the percentage of drivers who were female increased with the level of protective restraints that were used, but the investigators adjusted all their analyses for these variables as well as the year of injury.

The percentages of patients who developed ventilator-associated pneumonia and bacteremia followed the same pattern as injuries and mortality, with significantly lower rates as the level of protection increased.

By using data from an analysis of the economic impact of infection control, Dr. Fabian and his associates determined that hospital costs increased by about $10,000 for each episode of ventilator-associated pneumonia and about $34,000 for each episode of bacteremia (Am. J. Infect. Control 2005;33:542–7). When these costs were indexed to 100 motor vehicle accident patients, the costs of providing care to unrestrained patients rose by nearly $300,000. The use of air bags and seat belts alone or in combination substantially decreased that amount.

Patients who used both seat belts and air bags were estimated to save about $60,000 in the cost of ICU stays, which were valued at about $35,000 per day.

During the 11-year study period, if all 7,881 unrestrained patients had used seat belts and air bags, the trauma center would have saved more than $14 million in infectious morbidity costs and about $47 million in ICU stays, according to Dr. Fabian and his colleagues.

Other studies have shown that air bags decrease deaths at the scene of an accident, which “probably does mean we have more patients coming to the trauma center,” said Dr. Regan F. Williams, one of Dr. Fabian's coinvestigators. “What we chose to really concentrate on [in this study] is once the patients got to the trauma center. So this in no way is supposed to be a population-based study.”

HOT SPRINGS, VA. — Greater use of air bag restraints in motor vehicle accidents may not only save lives and reduce the rates of most injuries and infectious complications, but also save trauma centers millions of dollars, according to a review of patients treated at a trauma center over an 11-year period.

Air bags were found to reduce injuries to all parts of the body except the extremities. If all unrestrained patients admitted to the trauma center had used seat belts and air bags, more than $14 million would have been saved in costs of treating infections, as well as almost $50 million in ICU stays.

Since the National Highway Transportation and Safety Administration mandated airbags for the front driver's side in 1989 and the front passenger side in 1998, “there has been a fair amount of controversy that's developed about their safety,” Dr. Timothy C. Fabian reported at the annual meeting of the Southern Surgical Association.

While most studies of motor vehicle accidents at the scene of the accident have found significantly lower odds of death with the use of seat belts alone or seat belts combined with air bags, some studies have shown only very modest or no benefit from air bags alone.

“All these studies are basically analyses of accidents at the scene. What we chose to do was look at patients admitted to a level I trauma center to see outcomes on those individuals,” said Dr. Fabian, chairman of the surgery department at the University of Tennessee Health Science Center, Memphis.

“It's sort of closing the loop to some degree … compared to previous studies,” said Dr. Fabian, who also is one of the founders of the Elvis Presley Memorial Trauma Center at the Regional Medical Center at Memphis.

In a study of 14,390 victims of motor vehicle accidents who were taken to the Presley Memorial Trauma Center during 1996–2006, investigators divided the patients into those who were unrestrained (7,881), used an air bag alone (692), used a seat belt alone (4,909), or used both seat belt and air bag (908).

Compared with unrestrained patients, injuries to several body regions (brain, face, cervical spine, and chest), but not the extremities, significantly decreased with the use of an air bag alone, a seat belt alone, or a seat belt and air bag combined. Injuries to the extremities significantly increased with the use of an air bag alone or in conjunction with a seat belt, but not with a seat belt alone. Abdominal injuries declined significantly only with use of an air bag alone or in combination with a seat belt.

Hospital mortality, as well as number of days in the ICU and hospital, declined significantly as the level of restraint increased.

The age of drivers and the percentage of drivers who were female increased with the level of protective restraints that were used, but the investigators adjusted all their analyses for these variables as well as the year of injury.

The percentages of patients who developed ventilator-associated pneumonia and bacteremia followed the same pattern as injuries and mortality, with significantly lower rates as the level of protection increased.

By using data from an analysis of the economic impact of infection control, Dr. Fabian and his associates determined that hospital costs increased by about $10,000 for each episode of ventilator-associated pneumonia and about $34,000 for each episode of bacteremia (Am. J. Infect. Control 2005;33:542–7). When these costs were indexed to 100 motor vehicle accident patients, the costs of providing care to unrestrained patients rose by nearly $300,000. The use of air bags and seat belts alone or in combination substantially decreased that amount.

Patients who used both seat belts and air bags were estimated to save about $60,000 in the cost of ICU stays, which were valued at about $35,000 per day.

During the 11-year study period, if all 7,881 unrestrained patients had used seat belts and air bags, the trauma center would have saved more than $14 million in infectious morbidity costs and about $47 million in ICU stays, according to Dr. Fabian and his colleagues.

Other studies have shown that air bags decrease deaths at the scene of an accident, which “probably does mean we have more patients coming to the trauma center,” said Dr. Regan F. Williams, one of Dr. Fabian's coinvestigators. “What we chose to really concentrate on [in this study] is once the patients got to the trauma center. So this in no way is supposed to be a population-based study.”

HOT SPRINGS, VA. — Greater use of air bag restraints in motor vehicle accidents may not only save lives and reduce the rates of most injuries and infectious complications, but also save trauma centers millions of dollars, according to a review of patients treated at a trauma center over an 11-year period.

Air bags were found to reduce injuries to all parts of the body except the extremities. If all unrestrained patients admitted to the trauma center had used seat belts and air bags, more than $14 million would have been saved in costs of treating infections, as well as almost $50 million in ICU stays.

Since the National Highway Transportation and Safety Administration mandated airbags for the front driver's side in 1989 and the front passenger side in 1998, “there has been a fair amount of controversy that's developed about their safety,” Dr. Timothy C. Fabian reported at the annual meeting of the Southern Surgical Association.

While most studies of motor vehicle accidents at the scene of the accident have found significantly lower odds of death with the use of seat belts alone or seat belts combined with air bags, some studies have shown only very modest or no benefit from air bags alone.

“All these studies are basically analyses of accidents at the scene. What we chose to do was look at patients admitted to a level I trauma center to see outcomes on those individuals,” said Dr. Fabian, chairman of the surgery department at the University of Tennessee Health Science Center, Memphis.

“It's sort of closing the loop to some degree … compared to previous studies,” said Dr. Fabian, who also is one of the founders of the Elvis Presley Memorial Trauma Center at the Regional Medical Center at Memphis.

In a study of 14,390 victims of motor vehicle accidents who were taken to the Presley Memorial Trauma Center during 1996–2006, investigators divided the patients into those who were unrestrained (7,881), used an air bag alone (692), used a seat belt alone (4,909), or used both seat belt and air bag (908).

Compared with unrestrained patients, injuries to several body regions (brain, face, cervical spine, and chest), but not the extremities, significantly decreased with the use of an air bag alone, a seat belt alone, or a seat belt and air bag combined. Injuries to the extremities significantly increased with the use of an air bag alone or in conjunction with a seat belt, but not with a seat belt alone. Abdominal injuries declined significantly only with use of an air bag alone or in combination with a seat belt.

Hospital mortality, as well as number of days in the ICU and hospital, declined significantly as the level of restraint increased.

The age of drivers and the percentage of drivers who were female increased with the level of protective restraints that were used, but the investigators adjusted all their analyses for these variables as well as the year of injury.

The percentages of patients who developed ventilator-associated pneumonia and bacteremia followed the same pattern as injuries and mortality, with significantly lower rates as the level of protection increased.

By using data from an analysis of the economic impact of infection control, Dr. Fabian and his associates determined that hospital costs increased by about $10,000 for each episode of ventilator-associated pneumonia and about $34,000 for each episode of bacteremia (Am. J. Infect. Control 2005;33:542–7). When these costs were indexed to 100 motor vehicle accident patients, the costs of providing care to unrestrained patients rose by nearly $300,000. The use of air bags and seat belts alone or in combination substantially decreased that amount.

Patients who used both seat belts and air bags were estimated to save about $60,000 in the cost of ICU stays, which were valued at about $35,000 per day.

During the 11-year study period, if all 7,881 unrestrained patients had used seat belts and air bags, the trauma center would have saved more than $14 million in infectious morbidity costs and about $47 million in ICU stays, according to Dr. Fabian and his colleagues.

Other studies have shown that air bags decrease deaths at the scene of an accident, which “probably does mean we have more patients coming to the trauma center,” said Dr. Regan F. Williams, one of Dr. Fabian's coinvestigators. “What we chose to really concentrate on [in this study] is once the patients got to the trauma center. So this in no way is supposed to be a population-based study.”

CINCINNATI — Surgical site infections found in deep wounds or in organs or spaces manipulated during an operation might occur more often after general surgical procedures if patients have low blood albumin or are operated on through a previous incision, according to the results of a case-control study.

These new risk factors for surgical site infection (SSI) join old suspects—such as prolonged operative time and chronic obstructive pulmonary disease (COPD)—as independent predictors of any kind of SSI, according to a study presented by Dr. Manjunath Haridas at the annual meeting of the Central Surgical Association.

The risk factors should guide clinicians in their assessment of SSI risk and identify potential targets for intervention to reduce their incidence, said Dr. Haridas, a resident in the department of surgery at Case Western Reserve University, Cleveland.

During 2000–2006, 316 SSIs occurred in 10,253 general surgical procedures performed at one center. Dr. Haridas and his coinvestigator at Case Western, Dr. Mark Malangoni, compared 300 of these patients with SSIs with 300 matched control patients who also underwent surgery but did not develop an SSI (16 patients were excluded because no suitable matches could be found).

The patients, whose mean age was 56 years, underwent operations for the gastrointestinal tract, including the hepatobiliary system and pancreas (39% of patients); hernia repair (19%); and vascular (16%), breast (13%), and extra-abdominal areas (13%). They developed superficial (84%), deep (7%), or organ/space infections (9%).

Multivariate logistic regression revealed that reoperation through a previous incision was independently associated with 2.4-times higher odds of developing an SSI, whereas a prolonged operation (surgery time greater than the 75th percentile), a blood albumin level of 3.4 mg/dL or less, and COPD each were independently associated with 70%–80% greater odds of developing an SSI.

Patients who had either low blood albumin or a reoperation through a previous incision were between two and three times more likely to develop a deep or organ/space SSI than were those in which neither condition occurred.

It might be a good idea to take a postoperative surgical time-out to “reassess where you have been”; if more blood was lost or the operation took longer than expected, it could be worth keeping a closer eye on the patient, said Dr. Hiram C. Polk of the University of Louisville (Ky.), a discussant at the meeting.

Although the investigators did not record how many SSIs occurred in previously operated wounds that also had previously had an SSI, Dr. Malangoni thought that reoperation through a previously infected wound incision should be avoided because of the likelihood of reinfection after the second operation.

The investigators did not determine the rate of SSI in minimally invasive surgical procedures, but they did match patients with an SSI who underwent such procedures with those who did not have an SSI after a minimally invasive surgical approach. There did not appear to be a decrease in deep or organ/space SSIs with minimally invasive approaches.

CINCINNATI — Surgical site infections found in deep wounds or in organs or spaces manipulated during an operation might occur more often after general surgical procedures if patients have low blood albumin or are operated on through a previous incision, according to the results of a case-control study.

These new risk factors for surgical site infection (SSI) join old suspects—such as prolonged operative time and chronic obstructive pulmonary disease (COPD)—as independent predictors of any kind of SSI, according to a study presented by Dr. Manjunath Haridas at the annual meeting of the Central Surgical Association.

The risk factors should guide clinicians in their assessment of SSI risk and identify potential targets for intervention to reduce their incidence, said Dr. Haridas, a resident in the department of surgery at Case Western Reserve University, Cleveland.

During 2000–2006, 316 SSIs occurred in 10,253 general surgical procedures performed at one center. Dr. Haridas and his coinvestigator at Case Western, Dr. Mark Malangoni, compared 300 of these patients with SSIs with 300 matched control patients who also underwent surgery but did not develop an SSI (16 patients were excluded because no suitable matches could be found).

The patients, whose mean age was 56 years, underwent operations for the gastrointestinal tract, including the hepatobiliary system and pancreas (39% of patients); hernia repair (19%); and vascular (16%), breast (13%), and extra-abdominal areas (13%). They developed superficial (84%), deep (7%), or organ/space infections (9%).

Multivariate logistic regression revealed that reoperation through a previous incision was independently associated with 2.4-times higher odds of developing an SSI, whereas a prolonged operation (surgery time greater than the 75th percentile), a blood albumin level of 3.4 mg/dL or less, and COPD each were independently associated with 70%–80% greater odds of developing an SSI.

Patients who had either low blood albumin or a reoperation through a previous incision were between two and three times more likely to develop a deep or organ/space SSI than were those in which neither condition occurred.

It might be a good idea to take a postoperative surgical time-out to “reassess where you have been”; if more blood was lost or the operation took longer than expected, it could be worth keeping a closer eye on the patient, said Dr. Hiram C. Polk of the University of Louisville (Ky.), a discussant at the meeting.

Although the investigators did not record how many SSIs occurred in previously operated wounds that also had previously had an SSI, Dr. Malangoni thought that reoperation through a previously infected wound incision should be avoided because of the likelihood of reinfection after the second operation.

The investigators did not determine the rate of SSI in minimally invasive surgical procedures, but they did match patients with an SSI who underwent such procedures with those who did not have an SSI after a minimally invasive surgical approach. There did not appear to be a decrease in deep or organ/space SSIs with minimally invasive approaches.

CINCINNATI — Surgical site infections found in deep wounds or in organs or spaces manipulated during an operation might occur more often after general surgical procedures if patients have low blood albumin or are operated on through a previous incision, according to the results of a case-control study.

These new risk factors for surgical site infection (SSI) join old suspects—such as prolonged operative time and chronic obstructive pulmonary disease (COPD)—as independent predictors of any kind of SSI, according to a study presented by Dr. Manjunath Haridas at the annual meeting of the Central Surgical Association.

The risk factors should guide clinicians in their assessment of SSI risk and identify potential targets for intervention to reduce their incidence, said Dr. Haridas, a resident in the department of surgery at Case Western Reserve University, Cleveland.

During 2000–2006, 316 SSIs occurred in 10,253 general surgical procedures performed at one center. Dr. Haridas and his coinvestigator at Case Western, Dr. Mark Malangoni, compared 300 of these patients with SSIs with 300 matched control patients who also underwent surgery but did not develop an SSI (16 patients were excluded because no suitable matches could be found).

The patients, whose mean age was 56 years, underwent operations for the gastrointestinal tract, including the hepatobiliary system and pancreas (39% of patients); hernia repair (19%); and vascular (16%), breast (13%), and extra-abdominal areas (13%). They developed superficial (84%), deep (7%), or organ/space infections (9%).

Multivariate logistic regression revealed that reoperation through a previous incision was independently associated with 2.4-times higher odds of developing an SSI, whereas a prolonged operation (surgery time greater than the 75th percentile), a blood albumin level of 3.4 mg/dL or less, and COPD each were independently associated with 70%–80% greater odds of developing an SSI.

Patients who had either low blood albumin or a reoperation through a previous incision were between two and three times more likely to develop a deep or organ/space SSI than were those in which neither condition occurred.

It might be a good idea to take a postoperative surgical time-out to “reassess where you have been”; if more blood was lost or the operation took longer than expected, it could be worth keeping a closer eye on the patient, said Dr. Hiram C. Polk of the University of Louisville (Ky.), a discussant at the meeting.

Although the investigators did not record how many SSIs occurred in previously operated wounds that also had previously had an SSI, Dr. Malangoni thought that reoperation through a previously infected wound incision should be avoided because of the likelihood of reinfection after the second operation.

The investigators did not determine the rate of SSI in minimally invasive surgical procedures, but they did match patients with an SSI who underwent such procedures with those who did not have an SSI after a minimally invasive surgical approach. There did not appear to be a decrease in deep or organ/space SSIs with minimally invasive approaches.

BALTIMORE — Methods for determining how and when to use pharmacologic and mechanical interventions to prevent venous thromboembolism in surgical patients may remain open to debate, but the need for prophylaxis should not, Dr. Morey A. Blinder said at the annual meeting of the American Society of Plastic Surgeons.

Prophylaxis is underused because many physicians believe that the incidence of deep venous thrombosis (DVT) in hospitalized patients is "too low" to warrant its consideration, said Dr. Blinder of the division of hematology and the department of pathology and immunology at Washington University, St. Louis.

Other physicians voice concerns about bleeding complications—particularly in surgical patients—and about heparin-induced thrombocytopenia, which occurs in 1%–2% of patients on heparin.

"Many clinicians have the sense that venous thrombosis is not a particular problem in their practice," because they have not seen a DVT in one of their patients for several years or may have not known that a patient had a DVT diagnosed a week after surgery by an internist or at the emergency department, Dr. Blinder said.

In the absence of prophylaxis, studies have found a DVT prevalence of 10%–20% in medical patients, 15%–40% in general surgery patients, and about 20%–50% of stroke and orthopedic surgery patients. Even though most patients did not have symptomatic thrombosis in those studies, each patient underwent venography or a fibrinogen uptake procedure. Most series of major procedures in plastic surgery have found a risk of 1%–2% for DVT and/or pulmonary embolism, generally without prophylaxis, he said.

Deficiencies in any of the body's natural anticoagulants, such as antithrombin, protein C, and protein S, lead to a substantial risk of thrombosis. About 5% of people with European heritage carry a mutation in the blood-clotting factor V Leiden, which increases the risk of thrombosis. In fact, 20%–30% of people who have DVT without an identified cause turn out to be positive for the factor V Leiden mutation.

"We've seen many, many patients who have [a factor V Leiden mutation] as an inherited risk factor, and then you add on a second risk factor like surgery or like an estrogen-containing hormone, and that is enough to trigger a blood clot," Dr. Blinder said.

The American College of Chest Physicians' evidence-based guidelines for preventing venous thromboembolism stratify patients undergoing general surgery as low, moderate, high, or highest risk, according to their age, the type of operation, and underlying risk factors (Chest 2004;126:338S-400S).

The guidelines advise early and frequent mobilization for low-risk patients and low-dose unfractionated heparin (LDUH) or low-molecular weight heparin (LMWH) for moderate-risk patients. High-risk patients generally should receive LDUH every 8 hours, or a LMWH such as enoxaparin (Lovenox).

Patients at highest risk for DVT need a full dose of a LMWH such as enoxaparin or the factor Xa inhibitor fondaparinux (Arixtra) in combination with intermittent pneumatic compression (IPC) or graduated compression stockings, said Dr. Blinder, who is on the speakers bureau for GlaxoSmithKline Inc., which manufactures fondaparinux.

Other guidelines that have been issued by the American Society of Plastic Surgeons largely follow these recommendations but instead divide surgical patients into low-, moderate-, and high-risk groups (Plast. Reconstr. Surg. 2002;110:1337–42).

Dr. Blinder suggested that IPC devices may see rising use because newer, fanny pack-size devices are much smaller than previous ones that had to sit at the side of a bed. Graduated compression stockings are thought to increase blood circulation by restricting the venous diameter. IPC devices also restrict venous diameter and are known to more than double the velocity of blood and increase fibrinolytic activity.

A meta-analysis of 15 randomized, controlled trials using IPC to prevent DVT in surgical patients found that the devices could drop the risk of DVT by 60%, compared with no prophylaxis (Thromb. Haemost. 2005;94:1181–5).

Investigators have not resolved the appropriate time to start or stop prophylaxis, but some type of pharmacologic prophylaxis should be included along with mechanical methods, he advised.

BALTIMORE — Methods for determining how and when to use pharmacologic and mechanical interventions to prevent venous thromboembolism in surgical patients may remain open to debate, but the need for prophylaxis should not, Dr. Morey A. Blinder said at the annual meeting of the American Society of Plastic Surgeons.

Prophylaxis is underused because many physicians believe that the incidence of deep venous thrombosis (DVT) in hospitalized patients is "too low" to warrant its consideration, said Dr. Blinder of the division of hematology and the department of pathology and immunology at Washington University, St. Louis.

Other physicians voice concerns about bleeding complications—particularly in surgical patients—and about heparin-induced thrombocytopenia, which occurs in 1%–2% of patients on heparin.

"Many clinicians have the sense that venous thrombosis is not a particular problem in their practice," because they have not seen a DVT in one of their patients for several years or may have not known that a patient had a DVT diagnosed a week after surgery by an internist or at the emergency department, Dr. Blinder said.

In the absence of prophylaxis, studies have found a DVT prevalence of 10%–20% in medical patients, 15%–40% in general surgery patients, and about 20%–50% of stroke and orthopedic surgery patients. Even though most patients did not have symptomatic thrombosis in those studies, each patient underwent venography or a fibrinogen uptake procedure. Most series of major procedures in plastic surgery have found a risk of 1%–2% for DVT and/or pulmonary embolism, generally without prophylaxis, he said.

Deficiencies in any of the body's natural anticoagulants, such as antithrombin, protein C, and protein S, lead to a substantial risk of thrombosis. About 5% of people with European heritage carry a mutation in the blood-clotting factor V Leiden, which increases the risk of thrombosis. In fact, 20%–30% of people who have DVT without an identified cause turn out to be positive for the factor V Leiden mutation.

"We've seen many, many patients who have [a factor V Leiden mutation] as an inherited risk factor, and then you add on a second risk factor like surgery or like an estrogen-containing hormone, and that is enough to trigger a blood clot," Dr. Blinder said.

The American College of Chest Physicians' evidence-based guidelines for preventing venous thromboembolism stratify patients undergoing general surgery as low, moderate, high, or highest risk, according to their age, the type of operation, and underlying risk factors (Chest 2004;126:338S-400S).

The guidelines advise early and frequent mobilization for low-risk patients and low-dose unfractionated heparin (LDUH) or low-molecular weight heparin (LMWH) for moderate-risk patients. High-risk patients generally should receive LDUH every 8 hours, or a LMWH such as enoxaparin (Lovenox).

Patients at highest risk for DVT need a full dose of a LMWH such as enoxaparin or the factor Xa inhibitor fondaparinux (Arixtra) in combination with intermittent pneumatic compression (IPC) or graduated compression stockings, said Dr. Blinder, who is on the speakers bureau for GlaxoSmithKline Inc., which manufactures fondaparinux.

Other guidelines that have been issued by the American Society of Plastic Surgeons largely follow these recommendations but instead divide surgical patients into low-, moderate-, and high-risk groups (Plast. Reconstr. Surg. 2002;110:1337–42).

Dr. Blinder suggested that IPC devices may see rising use because newer, fanny pack-size devices are much smaller than previous ones that had to sit at the side of a bed. Graduated compression stockings are thought to increase blood circulation by restricting the venous diameter. IPC devices also restrict venous diameter and are known to more than double the velocity of blood and increase fibrinolytic activity.

A meta-analysis of 15 randomized, controlled trials using IPC to prevent DVT in surgical patients found that the devices could drop the risk of DVT by 60%, compared with no prophylaxis (Thromb. Haemost. 2005;94:1181–5).

Investigators have not resolved the appropriate time to start or stop prophylaxis, but some type of pharmacologic prophylaxis should be included along with mechanical methods, he advised.

BALTIMORE — Methods for determining how and when to use pharmacologic and mechanical interventions to prevent venous thromboembolism in surgical patients may remain open to debate, but the need for prophylaxis should not, Dr. Morey A. Blinder said at the annual meeting of the American Society of Plastic Surgeons.

Prophylaxis is underused because many physicians believe that the incidence of deep venous thrombosis (DVT) in hospitalized patients is "too low" to warrant its consideration, said Dr. Blinder of the division of hematology and the department of pathology and immunology at Washington University, St. Louis.

Other physicians voice concerns about bleeding complications—particularly in surgical patients—and about heparin-induced thrombocytopenia, which occurs in 1%–2% of patients on heparin.

"Many clinicians have the sense that venous thrombosis is not a particular problem in their practice," because they have not seen a DVT in one of their patients for several years or may have not known that a patient had a DVT diagnosed a week after surgery by an internist or at the emergency department, Dr. Blinder said.

In the absence of prophylaxis, studies have found a DVT prevalence of 10%–20% in medical patients, 15%–40% in general surgery patients, and about 20%–50% of stroke and orthopedic surgery patients. Even though most patients did not have symptomatic thrombosis in those studies, each patient underwent venography or a fibrinogen uptake procedure. Most series of major procedures in plastic surgery have found a risk of 1%–2% for DVT and/or pulmonary embolism, generally without prophylaxis, he said.

Deficiencies in any of the body's natural anticoagulants, such as antithrombin, protein C, and protein S, lead to a substantial risk of thrombosis. About 5% of people with European heritage carry a mutation in the blood-clotting factor V Leiden, which increases the risk of thrombosis. In fact, 20%–30% of people who have DVT without an identified cause turn out to be positive for the factor V Leiden mutation.

"We've seen many, many patients who have [a factor V Leiden mutation] as an inherited risk factor, and then you add on a second risk factor like surgery or like an estrogen-containing hormone, and that is enough to trigger a blood clot," Dr. Blinder said.

The American College of Chest Physicians' evidence-based guidelines for preventing venous thromboembolism stratify patients undergoing general surgery as low, moderate, high, or highest risk, according to their age, the type of operation, and underlying risk factors (Chest 2004;126:338S-400S).

The guidelines advise early and frequent mobilization for low-risk patients and low-dose unfractionated heparin (LDUH) or low-molecular weight heparin (LMWH) for moderate-risk patients. High-risk patients generally should receive LDUH every 8 hours, or a LMWH such as enoxaparin (Lovenox).

Patients at highest risk for DVT need a full dose of a LMWH such as enoxaparin or the factor Xa inhibitor fondaparinux (Arixtra) in combination with intermittent pneumatic compression (IPC) or graduated compression stockings, said Dr. Blinder, who is on the speakers bureau for GlaxoSmithKline Inc., which manufactures fondaparinux.

Other guidelines that have been issued by the American Society of Plastic Surgeons largely follow these recommendations but instead divide surgical patients into low-, moderate-, and high-risk groups (Plast. Reconstr. Surg. 2002;110:1337–42).

Dr. Blinder suggested that IPC devices may see rising use because newer, fanny pack-size devices are much smaller than previous ones that had to sit at the side of a bed. Graduated compression stockings are thought to increase blood circulation by restricting the venous diameter. IPC devices also restrict venous diameter and are known to more than double the velocity of blood and increase fibrinolytic activity.

A meta-analysis of 15 randomized, controlled trials using IPC to prevent DVT in surgical patients found that the devices could drop the risk of DVT by 60%, compared with no prophylaxis (Thromb. Haemost. 2005;94:1181–5).

Investigators have not resolved the appropriate time to start or stop prophylaxis, but some type of pharmacologic prophylaxis should be included along with mechanical methods, he advised.

BALTIMORE — The cutaneous adhesive Dermabond can be applied to the margins of a wound to buttress atrophied, thin skin enough to achieve adequate primary closure with sutures, Dr. Michael Bain reported at the annual meeting of the American Society of Plastic Surgeons.

Physicians have always had a difficult time suturing lacerations or defects created from the removal of cancer because sutures tear the skin of older patients with steroid-induced skin atrophy or genetically thin skin, said Dr. Bain, a plastic surgeon in private practice in Newport Beach, Calif.

"There are so many patients out there who in the past have needed skin grafting when they got a bad laceration," he said in an interview. "You could also use this technique in infants who have very thin skin."

After a standard wound preparation, Dermabond is applied 3 mm from the wound margins. Simple sutures placed either through or behind the Dermabond close the wound without tearing the skin. "You have to make certain that you don't get any Dermabond into the incision or into the wound because that will prevent healing," he said.

Dr. Bain has used the technique on about 15–20 patients without any problems. He said that his colleagues, as well as trauma surgeons, also have begun using the technique successfully.

By allowing the closure of wounds in thin skin, the technique may prevent the need for prolonged wound care, according to Dr. Bain, who presented the method on a poster. He and his coinvestigators have no conflicts of interest with regard to Ethicon Inc., the manufacturer of Dermabond.

The cutaneous adhesive, Dermabond, is applied 3 mm from the wound margins.

The healing wound is shown 3 weeks after the graft-sparing procedure. Photos courtesy Dr. Michael Bain

BALTIMORE — The cutaneous adhesive Dermabond can be applied to the margins of a wound to buttress atrophied, thin skin enough to achieve adequate primary closure with sutures, Dr. Michael Bain reported at the annual meeting of the American Society of Plastic Surgeons.

Physicians have always had a difficult time suturing lacerations or defects created from the removal of cancer because sutures tear the skin of older patients with steroid-induced skin atrophy or genetically thin skin, said Dr. Bain, a plastic surgeon in private practice in Newport Beach, Calif.

"There are so many patients out there who in the past have needed skin grafting when they got a bad laceration," he said in an interview. "You could also use this technique in infants who have very thin skin."

After a standard wound preparation, Dermabond is applied 3 mm from the wound margins. Simple sutures placed either through or behind the Dermabond close the wound without tearing the skin. "You have to make certain that you don't get any Dermabond into the incision or into the wound because that will prevent healing," he said.

Dr. Bain has used the technique on about 15–20 patients without any problems. He said that his colleagues, as well as trauma surgeons, also have begun using the technique successfully.

By allowing the closure of wounds in thin skin, the technique may prevent the need for prolonged wound care, according to Dr. Bain, who presented the method on a poster. He and his coinvestigators have no conflicts of interest with regard to Ethicon Inc., the manufacturer of Dermabond.

The cutaneous adhesive, Dermabond, is applied 3 mm from the wound margins.

The healing wound is shown 3 weeks after the graft-sparing procedure. Photos courtesy Dr. Michael Bain

BALTIMORE — The cutaneous adhesive Dermabond can be applied to the margins of a wound to buttress atrophied, thin skin enough to achieve adequate primary closure with sutures, Dr. Michael Bain reported at the annual meeting of the American Society of Plastic Surgeons.

Physicians have always had a difficult time suturing lacerations or defects created from the removal of cancer because sutures tear the skin of older patients with steroid-induced skin atrophy or genetically thin skin, said Dr. Bain, a plastic surgeon in private practice in Newport Beach, Calif.

"There are so many patients out there who in the past have needed skin grafting when they got a bad laceration," he said in an interview. "You could also use this technique in infants who have very thin skin."

After a standard wound preparation, Dermabond is applied 3 mm from the wound margins. Simple sutures placed either through or behind the Dermabond close the wound without tearing the skin. "You have to make certain that you don't get any Dermabond into the incision or into the wound because that will prevent healing," he said.

Dr. Bain has used the technique on about 15–20 patients without any problems. He said that his colleagues, as well as trauma surgeons, also have begun using the technique successfully.

By allowing the closure of wounds in thin skin, the technique may prevent the need for prolonged wound care, according to Dr. Bain, who presented the method on a poster. He and his coinvestigators have no conflicts of interest with regard to Ethicon Inc., the manufacturer of Dermabond.

The cutaneous adhesive, Dermabond, is applied 3 mm from the wound margins.

The healing wound is shown 3 weeks after the graft-sparing procedure. Photos courtesy Dr. Michael Bain

BALTIMORE — Oasis wound matrix provides a low-maintenance scaffold for split-thickness skin graft donor sites to grow new epidermis over several weeks without significant pain for the patient, Dr. James C. Yuen said in a poster presented at the annual meeting of the American Society of Plastic Surgeons.

Since Oasis was approved by the Food and Drug Administration in 2000, few articles have been published on its use, none of which describes using it for dressing split-thickness skin graft donor sites, according to Dr. Yuen of the division of plastic and reconstructive surgery at the University of Arkansas, Little Rock.

Oasis is derived from porcine intestinal mucosa and acts as an extracellular matrix to support cell adherence, he said.

The material contains key components of the dermal extracellular matrix (collagen, elastin, glycosaminoglycans, glycoproteins, proteoglycans, and growth hormones) to promote rapid cellular proliferation and capillary ingrowth.

During 2003–2006, Dr. Yuen and his colleague, Dr. Julio Hochberg, also of the university, used Oasis to reepithelialize split-thickness skin graft donor sites on the thighs of 131 patients.

Epithelialization was complete after 1–3 weeks in all but two patients who had delayed healing beyond 1 month. Few patients experienced significant pain at the donor site because the material protects nerve endings, the investigators suggested.

Once Oasis is placed directly over the wound, Xeroform (Kendall Inc.) is placed to cover the matrix, followed by nonadherent Telfa gauze (Kendall), 4-by-4-inch dry gauze pads, and then Tegaderm tape (3M Health Care) for smaller donor sites or a circumferential wrap with Kerlix (Kendall) for larger sites. Dr. Yuen said that neither he nor Dr. Hochberg has any conflicts of interest with the manufacturers of any the products used in the procedure.

The investigators typically changed the dressing 4–6 days after surgery, but it was done earlier if there was excessive drainage soaking through the dressing.

Subsequent dressing changes occurred every 2–3 days, leaving the Oasis wound matrix and Xeroform in place each time.

The scab-like wound matrix peels off easily after reepithelialization is complete, Dr. Yuen said.

BALTIMORE — Oasis wound matrix provides a low-maintenance scaffold for split-thickness skin graft donor sites to grow new epidermis over several weeks without significant pain for the patient, Dr. James C. Yuen said in a poster presented at the annual meeting of the American Society of Plastic Surgeons.

Since Oasis was approved by the Food and Drug Administration in 2000, few articles have been published on its use, none of which describes using it for dressing split-thickness skin graft donor sites, according to Dr. Yuen of the division of plastic and reconstructive surgery at the University of Arkansas, Little Rock.

Oasis is derived from porcine intestinal mucosa and acts as an extracellular matrix to support cell adherence, he said.

The material contains key components of the dermal extracellular matrix (collagen, elastin, glycosaminoglycans, glycoproteins, proteoglycans, and growth hormones) to promote rapid cellular proliferation and capillary ingrowth.

During 2003–2006, Dr. Yuen and his colleague, Dr. Julio Hochberg, also of the university, used Oasis to reepithelialize split-thickness skin graft donor sites on the thighs of 131 patients.

Epithelialization was complete after 1–3 weeks in all but two patients who had delayed healing beyond 1 month. Few patients experienced significant pain at the donor site because the material protects nerve endings, the investigators suggested.

Once Oasis is placed directly over the wound, Xeroform (Kendall Inc.) is placed to cover the matrix, followed by nonadherent Telfa gauze (Kendall), 4-by-4-inch dry gauze pads, and then Tegaderm tape (3M Health Care) for smaller donor sites or a circumferential wrap with Kerlix (Kendall) for larger sites. Dr. Yuen said that neither he nor Dr. Hochberg has any conflicts of interest with the manufacturers of any the products used in the procedure.

The investigators typically changed the dressing 4–6 days after surgery, but it was done earlier if there was excessive drainage soaking through the dressing.

Subsequent dressing changes occurred every 2–3 days, leaving the Oasis wound matrix and Xeroform in place each time.

The scab-like wound matrix peels off easily after reepithelialization is complete, Dr. Yuen said.

BALTIMORE — Oasis wound matrix provides a low-maintenance scaffold for split-thickness skin graft donor sites to grow new epidermis over several weeks without significant pain for the patient, Dr. James C. Yuen said in a poster presented at the annual meeting of the American Society of Plastic Surgeons.

Since Oasis was approved by the Food and Drug Administration in 2000, few articles have been published on its use, none of which describes using it for dressing split-thickness skin graft donor sites, according to Dr. Yuen of the division of plastic and reconstructive surgery at the University of Arkansas, Little Rock.

Oasis is derived from porcine intestinal mucosa and acts as an extracellular matrix to support cell adherence, he said.

The material contains key components of the dermal extracellular matrix (collagen, elastin, glycosaminoglycans, glycoproteins, proteoglycans, and growth hormones) to promote rapid cellular proliferation and capillary ingrowth.

During 2003–2006, Dr. Yuen and his colleague, Dr. Julio Hochberg, also of the university, used Oasis to reepithelialize split-thickness skin graft donor sites on the thighs of 131 patients.

Epithelialization was complete after 1–3 weeks in all but two patients who had delayed healing beyond 1 month. Few patients experienced significant pain at the donor site because the material protects nerve endings, the investigators suggested.

Once Oasis is placed directly over the wound, Xeroform (Kendall Inc.) is placed to cover the matrix, followed by nonadherent Telfa gauze (Kendall), 4-by-4-inch dry gauze pads, and then Tegaderm tape (3M Health Care) for smaller donor sites or a circumferential wrap with Kerlix (Kendall) for larger sites. Dr. Yuen said that neither he nor Dr. Hochberg has any conflicts of interest with the manufacturers of any the products used in the procedure.

The investigators typically changed the dressing 4–6 days after surgery, but it was done earlier if there was excessive drainage soaking through the dressing.

Subsequent dressing changes occurred every 2–3 days, leaving the Oasis wound matrix and Xeroform in place each time.

The scab-like wound matrix peels off easily after reepithelialization is complete, Dr. Yuen said.

BALTIMORE – A preliminary study of nearly 600,000 electronic medical records validates reports in the literature showing that about 20% of female and 1% of male Veterans Affairs patients have reported military sexual trauma.

“Because there are so many more males than females in the VA health care system, the [actual] sizes of our clinical populations are about equal,” with about 57,000 victims in each gender,” Rachel Kimerling, Ph.D., of the National Center for Posttraumatic Stress Disorder in the VA Palo Alto (Calif.) Health Care System, said at the annual meeting of the International Society for Traumatic Stress Studies.

The results of the study that Dr. Kimerling and her colleagues conducted reinforce the need to provide adequate treatment for victims. They also suggest that mandatory screening for a history of military sexual trauma (MST) in veterans receiving VA health care services has been effective and “pretty efficient” in finding and treating enough patients to make its implementation worthwhile.

MST is defined as sexual assault or repeated, unsolicited, threatening acts of sexual harassment that occur during active military duty or training for active duty.

In one of Dr. Kimerling's previous studies of the VA MST screening program, women with MST were almost nine times more likely to have posttraumatic stress disorder (PTSD) than women who did not report MST, whereas men with MST were three times more likely to have PTSD than men without a history of MST. Positive screens for MST were associated with greater odds of many mental health and medical comorbidities (Am. J. Public Health 2007;97:2160-6).

A public law implemented in 2001 mandates universal screening for MST for both genders in VA health care settings. Patients who screen positive are offered treatment of MST-related conditions free of charge, regardless of VA eligibility.

Dr. Kimerling said the services research usually suggests that screening alone is not very helpful. “But I thought it was worth checking out, because of the depth of these policies and the mandate, and because I think sexual trauma is a little bit of a special population [in which] there is such a pronounced stigma, especially for the male patient. It is so rarely disclosed to providers that screening actually might do something to make people aware that VA actually treats this and that services are available.”

She and her associates conducted a preliminary prospective longitudinal study of patients screened for MST at VA medical centers in 2005. Screening found that MST was prevalent in just over 1% of 540,381 male and almost 20% of 33,259 female VA patients. Most of the screened population had no prior mental health care, defined as any contact with specialty mental health or substance abuse services within the past 6 months (90% of men and 86% of women).

Screening for MST was positive if the reply to either of the following questions was “yes:”

▸ While you were in the military, did you receive unwanted sexual attention, such as touching, cornering, pressure for sexual favors, or verbal remarks?

▸ While you were in the military, did someone ever use force or threats of force or punishment to have sexual contact with you when you did not want to?

“What you expect to see if [screening] was working is more mental health service use after screening than before screening,” Dr. Kimerling said. Women who screened positive for MST were 2.5 times more likely to obtain mental health care after being screened than were women who screened negative for MST; this difference was significant (30% of MST positive vs. 12% of MST negative).

Men who screened positive for MST (23%) had nearly the same increased probability of getting mental health care after being screened, compared with men who had screened negative (9%).

MST-positive patients who had a history of mental health treatment, including those already in ongoing treatment, were 20%-25% more likely to obtain mental health care after screening than were those who had a history of mental health treatment but screened negative for MST. The differences were significant in men (79% vs. 66%) and women (77% vs. 62%). All comparisons were adjusted for age and race, Dr. Kimerling said at the meeting, which was also sponsored by Boston University.

BALTIMORE – A preliminary study of nearly 600,000 electronic medical records validates reports in the literature showing that about 20% of female and 1% of male Veterans Affairs patients have reported military sexual trauma.

“Because there are so many more males than females in the VA health care system, the [actual] sizes of our clinical populations are about equal,” with about 57,000 victims in each gender,” Rachel Kimerling, Ph.D., of the National Center for Posttraumatic Stress Disorder in the VA Palo Alto (Calif.) Health Care System, said at the annual meeting of the International Society for Traumatic Stress Studies.

The results of the study that Dr. Kimerling and her colleagues conducted reinforce the need to provide adequate treatment for victims. They also suggest that mandatory screening for a history of military sexual trauma (MST) in veterans receiving VA health care services has been effective and “pretty efficient” in finding and treating enough patients to make its implementation worthwhile.

MST is defined as sexual assault or repeated, unsolicited, threatening acts of sexual harassment that occur during active military duty or training for active duty.

In one of Dr. Kimerling's previous studies of the VA MST screening program, women with MST were almost nine times more likely to have posttraumatic stress disorder (PTSD) than women who did not report MST, whereas men with MST were three times more likely to have PTSD than men without a history of MST. Positive screens for MST were associated with greater odds of many mental health and medical comorbidities (Am. J. Public Health 2007;97:2160-6).

A public law implemented in 2001 mandates universal screening for MST for both genders in VA health care settings. Patients who screen positive are offered treatment of MST-related conditions free of charge, regardless of VA eligibility.

Dr. Kimerling said the services research usually suggests that screening alone is not very helpful. “But I thought it was worth checking out, because of the depth of these policies and the mandate, and because I think sexual trauma is a little bit of a special population [in which] there is such a pronounced stigma, especially for the male patient. It is so rarely disclosed to providers that screening actually might do something to make people aware that VA actually treats this and that services are available.”

She and her associates conducted a preliminary prospective longitudinal study of patients screened for MST at VA medical centers in 2005. Screening found that MST was prevalent in just over 1% of 540,381 male and almost 20% of 33,259 female VA patients. Most of the screened population had no prior mental health care, defined as any contact with specialty mental health or substance abuse services within the past 6 months (90% of men and 86% of women).

Screening for MST was positive if the reply to either of the following questions was “yes:”

▸ While you were in the military, did you receive unwanted sexual attention, such as touching, cornering, pressure for sexual favors, or verbal remarks?

▸ While you were in the military, did someone ever use force or threats of force or punishment to have sexual contact with you when you did not want to?

“What you expect to see if [screening] was working is more mental health service use after screening than before screening,” Dr. Kimerling said. Women who screened positive for MST were 2.5 times more likely to obtain mental health care after being screened than were women who screened negative for MST; this difference was significant (30% of MST positive vs. 12% of MST negative).

Men who screened positive for MST (23%) had nearly the same increased probability of getting mental health care after being screened, compared with men who had screened negative (9%).

MST-positive patients who had a history of mental health treatment, including those already in ongoing treatment, were 20%-25% more likely to obtain mental health care after screening than were those who had a history of mental health treatment but screened negative for MST. The differences were significant in men (79% vs. 66%) and women (77% vs. 62%). All comparisons were adjusted for age and race, Dr. Kimerling said at the meeting, which was also sponsored by Boston University.

BALTIMORE – A preliminary study of nearly 600,000 electronic medical records validates reports in the literature showing that about 20% of female and 1% of male Veterans Affairs patients have reported military sexual trauma.

“Because there are so many more males than females in the VA health care system, the [actual] sizes of our clinical populations are about equal,” with about 57,000 victims in each gender,” Rachel Kimerling, Ph.D., of the National Center for Posttraumatic Stress Disorder in the VA Palo Alto (Calif.) Health Care System, said at the annual meeting of the International Society for Traumatic Stress Studies.

The results of the study that Dr. Kimerling and her colleagues conducted reinforce the need to provide adequate treatment for victims. They also suggest that mandatory screening for a history of military sexual trauma (MST) in veterans receiving VA health care services has been effective and “pretty efficient” in finding and treating enough patients to make its implementation worthwhile.

MST is defined as sexual assault or repeated, unsolicited, threatening acts of sexual harassment that occur during active military duty or training for active duty.

In one of Dr. Kimerling's previous studies of the VA MST screening program, women with MST were almost nine times more likely to have posttraumatic stress disorder (PTSD) than women who did not report MST, whereas men with MST were three times more likely to have PTSD than men without a history of MST. Positive screens for MST were associated with greater odds of many mental health and medical comorbidities (Am. J. Public Health 2007;97:2160-6).

A public law implemented in 2001 mandates universal screening for MST for both genders in VA health care settings. Patients who screen positive are offered treatment of MST-related conditions free of charge, regardless of VA eligibility.

Dr. Kimerling said the services research usually suggests that screening alone is not very helpful. “But I thought it was worth checking out, because of the depth of these policies and the mandate, and because I think sexual trauma is a little bit of a special population [in which] there is such a pronounced stigma, especially for the male patient. It is so rarely disclosed to providers that screening actually might do something to make people aware that VA actually treats this and that services are available.”

She and her associates conducted a preliminary prospective longitudinal study of patients screened for MST at VA medical centers in 2005. Screening found that MST was prevalent in just over 1% of 540,381 male and almost 20% of 33,259 female VA patients. Most of the screened population had no prior mental health care, defined as any contact with specialty mental health or substance abuse services within the past 6 months (90% of men and 86% of women).

Screening for MST was positive if the reply to either of the following questions was “yes:”

▸ While you were in the military, did you receive unwanted sexual attention, such as touching, cornering, pressure for sexual favors, or verbal remarks?

▸ While you were in the military, did someone ever use force or threats of force or punishment to have sexual contact with you when you did not want to?

“What you expect to see if [screening] was working is more mental health service use after screening than before screening,” Dr. Kimerling said. Women who screened positive for MST were 2.5 times more likely to obtain mental health care after being screened than were women who screened negative for MST; this difference was significant (30% of MST positive vs. 12% of MST negative).

Men who screened positive for MST (23%) had nearly the same increased probability of getting mental health care after being screened, compared with men who had screened negative (9%).

MST-positive patients who had a history of mental health treatment, including those already in ongoing treatment, were 20%-25% more likely to obtain mental health care after screening than were those who had a history of mental health treatment but screened negative for MST. The differences were significant in men (79% vs. 66%) and women (77% vs. 62%). All comparisons were adjusted for age and race, Dr. Kimerling said at the meeting, which was also sponsored by Boston University.

In women with polycystic ovary syndrome, insulin resistance may be more severe in those with metabolic syndrome than in those without it, according to the results of a cross-sectional study of 113 women with PCOS.

The findings suggest that even young women with PCOS should be screened for metabolic disturbances to more effectively prevent cardiovascular events later in life, wrote Dr. Hwi Ra Park of the Ewha Woman's University College of Medicine, Seoul, South Korea, and colleagues.

Women in the study had a mean age of 26 years and a 15% prevalence of metabolic syndrome (MS)—lower than in other studies of PCOS patients in the United States (43%–46%) and Germany (31%). In comparison, MS prevalence is about 4% in the general urban population of age-matched Korean women and about 6% in American women aged 20–29 years (Diabetes Res. Clin. Pract. 2007;77[suppl. 1]:S243–6).

Investigators measured the five components that make up the diagnosis of metabolic syndrome according to the National Cholesterol Education Program Adult Treatment Panel III,

Compared with women who didn't have MS, those with MS had a significantly higher body mass index, waist girth, systolic and diastolic blood pressures, fasting glucose, and triglycerides. Levels of HDL cholesterol, sex hormone-binding globulin, and luteinizing hormone were significantly lower in women with MS.

The results of a 75-g oral glucose tolerance test that was performed in the morning after an overnight fast showed that plasma glucose and insulin levels were significantly higher in women with MS than in those without it.

In women with polycystic ovary syndrome, insulin resistance may be more severe in those with metabolic syndrome than in those without it, according to the results of a cross-sectional study of 113 women with PCOS.

The findings suggest that even young women with PCOS should be screened for metabolic disturbances to more effectively prevent cardiovascular events later in life, wrote Dr. Hwi Ra Park of the Ewha Woman's University College of Medicine, Seoul, South Korea, and colleagues.

Women in the study had a mean age of 26 years and a 15% prevalence of metabolic syndrome (MS)—lower than in other studies of PCOS patients in the United States (43%–46%) and Germany (31%). In comparison, MS prevalence is about 4% in the general urban population of age-matched Korean women and about 6% in American women aged 20–29 years (Diabetes Res. Clin. Pract. 2007;77[suppl. 1]:S243–6).

Investigators measured the five components that make up the diagnosis of metabolic syndrome according to the National Cholesterol Education Program Adult Treatment Panel III,

Compared with women who didn't have MS, those with MS had a significantly higher body mass index, waist girth, systolic and diastolic blood pressures, fasting glucose, and triglycerides. Levels of HDL cholesterol, sex hormone-binding globulin, and luteinizing hormone were significantly lower in women with MS.

The results of a 75-g oral glucose tolerance test that was performed in the morning after an overnight fast showed that plasma glucose and insulin levels were significantly higher in women with MS than in those without it.

In women with polycystic ovary syndrome, insulin resistance may be more severe in those with metabolic syndrome than in those without it, according to the results of a cross-sectional study of 113 women with PCOS.

The findings suggest that even young women with PCOS should be screened for metabolic disturbances to more effectively prevent cardiovascular events later in life, wrote Dr. Hwi Ra Park of the Ewha Woman's University College of Medicine, Seoul, South Korea, and colleagues.

Women in the study had a mean age of 26 years and a 15% prevalence of metabolic syndrome (MS)—lower than in other studies of PCOS patients in the United States (43%–46%) and Germany (31%). In comparison, MS prevalence is about 4% in the general urban population of age-matched Korean women and about 6% in American women aged 20–29 years (Diabetes Res. Clin. Pract. 2007;77[suppl. 1]:S243–6).

Investigators measured the five components that make up the diagnosis of metabolic syndrome according to the National Cholesterol Education Program Adult Treatment Panel III,

Compared with women who didn't have MS, those with MS had a significantly higher body mass index, waist girth, systolic and diastolic blood pressures, fasting glucose, and triglycerides. Levels of HDL cholesterol, sex hormone-binding globulin, and luteinizing hormone were significantly lower in women with MS.

The results of a 75-g oral glucose tolerance test that was performed in the morning after an overnight fast showed that plasma glucose and insulin levels were significantly higher in women with MS than in those without it.

The Food and Drug Administration has requested manufacturers and distributors of unapproved cough suppressants containing hydrocodone to stop marketing their products or face legal action.

“The industry has been and is well aware that its drugs were and are being marketed illegally, and the industry continues to circumvent the law and put consumers' health at risk. Nonetheless, the CPG [the FDA's Compliance Policy Guide for marketed unapproved drugs] provided the industry with specific notice that any illegally marketed unapproved drug is subject to FDA enforcement at any time,” Deborah M. Autor, J.D., said during a teleconference.

This is the sixth time that the agency has requested marketers of unapproved drugs to stop manufacturing and distributing unapproved products since the FDA began a targeted initiative against them in 2006.

The FDA has identified about 200 unapproved prescription antitussive drugs on the market that contain hydrocodone. Only seven prescription hydrocodone-containing cough suppressants are FDA approved: Hycodan (ENDO Pharms), Mycodone (Morton Grove), Tussicaps (Tyco Healthcare), Tussigon (King Pharmaceuticals), Tussionex Pennkinetic (UCB Inc.), Hydrocodone compound (Actavis Mid Atlantic), and Homatropine methylbromide and hydrocodone bitartrate (Actavis Totowa). Other approved cough suppressants do not contain hydrocodone. The agency did not identify any unapproved pain-relief medications containing hydrocodone.

Of particular concern to the agency are unapproved hydrocodone-containing cough suppressants that carry labels with dosing instructions for children as young as age 2 years, because no antitussive containing hydrocodone has been established as safe and effective for children younger than age 6 years. Other unapproved hydrocodone products have omitted important safety warnings and other information on their labeling, according to the FDA.

Hydrocodone-containing products have potential for adverse events such as psychotic behavior and drug abuse; nausea, vomiting, and constipation; cardiac arrest and respiratory depression; hypersensitivity, including pruritus, dermatitis, and pharyngeal edema; and intentional and unintentional overdose, according to the FDA.

More than 400 spontaneous reports of serious adverse events associated with antitussives containing hydrocodone have been reported to the FDA's voluntary MedWatch program since 2005, including deaths due to overdose, although the agency cannot separate out those pertaining to unapproved versus approved products, Dr. Jason Woo, associate director of medical and scientific affairs at the FDA's Office of Compliance, said during the teleconference.

The agency also has had reports of medication errors associated with formulation changes of unapproved hydrocodone-containing antitussives, such as changing the strength of the active ingredient, and reports of confusion over the similarity between the trade names of these unapproved products and other drug products.

“The mix-ups are a particular concern with these products. These products might be confused with one another, leading to dosing problems,” said Ms. Autor, director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research. “For example, in our NDC [National Drug Code] Directory … there are drugs named Histex and drugs named Histinex, and there are also drugs names Histuss HC, Histussin D, and Histussin HC.”

Before the FDA approves a trade name for a drug, agency researchers “make sure that we have done everything to prevent … names that sound alike or look alike or might be written alike. When a drug evades the FDA approval process, that entire process is not brought to bear,” she added. These similarly named products can contain different ingredients, so that a physician could write a prescription for a product containing one set of ingredients but actually get a similarly named product with different ingredients, Ms. Autor said.

Companies marketing unapproved hydrocodone-containing products that are labeled for use in children younger than age 6 years were required to end manufacturing and distribution of the products by Oct. 31. Marketers of other unapproved hydrocodone-containing products must stop manufacturing them by Dec. 31 and cease further shipment by March 31, 2008.

The Food and Drug Administration has requested manufacturers and distributors of unapproved cough suppressants containing hydrocodone to stop marketing their products or face legal action.

“The industry has been and is well aware that its drugs were and are being marketed illegally, and the industry continues to circumvent the law and put consumers' health at risk. Nonetheless, the CPG [the FDA's Compliance Policy Guide for marketed unapproved drugs] provided the industry with specific notice that any illegally marketed unapproved drug is subject to FDA enforcement at any time,” Deborah M. Autor, J.D., said during a teleconference.

This is the sixth time that the agency has requested marketers of unapproved drugs to stop manufacturing and distributing unapproved products since the FDA began a targeted initiative against them in 2006.

The FDA has identified about 200 unapproved prescription antitussive drugs on the market that contain hydrocodone. Only seven prescription hydrocodone-containing cough suppressants are FDA approved: Hycodan (ENDO Pharms), Mycodone (Morton Grove), Tussicaps (Tyco Healthcare), Tussigon (King Pharmaceuticals), Tussionex Pennkinetic (UCB Inc.), Hydrocodone compound (Actavis Mid Atlantic), and Homatropine methylbromide and hydrocodone bitartrate (Actavis Totowa). Other approved cough suppressants do not contain hydrocodone. The agency did not identify any unapproved pain-relief medications containing hydrocodone.

Of particular concern to the agency are unapproved hydrocodone-containing cough suppressants that carry labels with dosing instructions for children as young as age 2 years, because no antitussive containing hydrocodone has been established as safe and effective for children younger than age 6 years. Other unapproved hydrocodone products have omitted important safety warnings and other information on their labeling, according to the FDA.

Hydrocodone-containing products have potential for adverse events such as psychotic behavior and drug abuse; nausea, vomiting, and constipation; cardiac arrest and respiratory depression; hypersensitivity, including pruritus, dermatitis, and pharyngeal edema; and intentional and unintentional overdose, according to the FDA.

More than 400 spontaneous reports of serious adverse events associated with antitussives containing hydrocodone have been reported to the FDA's voluntary MedWatch program since 2005, including deaths due to overdose, although the agency cannot separate out those pertaining to unapproved versus approved products, Dr. Jason Woo, associate director of medical and scientific affairs at the FDA's Office of Compliance, said during the teleconference.

The agency also has had reports of medication errors associated with formulation changes of unapproved hydrocodone-containing antitussives, such as changing the strength of the active ingredient, and reports of confusion over the similarity between the trade names of these unapproved products and other drug products.

“The mix-ups are a particular concern with these products. These products might be confused with one another, leading to dosing problems,” said Ms. Autor, director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research. “For example, in our NDC [National Drug Code] Directory … there are drugs named Histex and drugs named Histinex, and there are also drugs names Histuss HC, Histussin D, and Histussin HC.”

Before the FDA approves a trade name for a drug, agency researchers “make sure that we have done everything to prevent … names that sound alike or look alike or might be written alike. When a drug evades the FDA approval process, that entire process is not brought to bear,” she added. These similarly named products can contain different ingredients, so that a physician could write a prescription for a product containing one set of ingredients but actually get a similarly named product with different ingredients, Ms. Autor said.

Companies marketing unapproved hydrocodone-containing products that are labeled for use in children younger than age 6 years were required to end manufacturing and distribution of the products by Oct. 31. Marketers of other unapproved hydrocodone-containing products must stop manufacturing them by Dec. 31 and cease further shipment by March 31, 2008.

The Food and Drug Administration has requested manufacturers and distributors of unapproved cough suppressants containing hydrocodone to stop marketing their products or face legal action.

“The industry has been and is well aware that its drugs were and are being marketed illegally, and the industry continues to circumvent the law and put consumers' health at risk. Nonetheless, the CPG [the FDA's Compliance Policy Guide for marketed unapproved drugs] provided the industry with specific notice that any illegally marketed unapproved drug is subject to FDA enforcement at any time,” Deborah M. Autor, J.D., said during a teleconference.

This is the sixth time that the agency has requested marketers of unapproved drugs to stop manufacturing and distributing unapproved products since the FDA began a targeted initiative against them in 2006.

The FDA has identified about 200 unapproved prescription antitussive drugs on the market that contain hydrocodone. Only seven prescription hydrocodone-containing cough suppressants are FDA approved: Hycodan (ENDO Pharms), Mycodone (Morton Grove), Tussicaps (Tyco Healthcare), Tussigon (King Pharmaceuticals), Tussionex Pennkinetic (UCB Inc.), Hydrocodone compound (Actavis Mid Atlantic), and Homatropine methylbromide and hydrocodone bitartrate (Actavis Totowa). Other approved cough suppressants do not contain hydrocodone. The agency did not identify any unapproved pain-relief medications containing hydrocodone.

Of particular concern to the agency are unapproved hydrocodone-containing cough suppressants that carry labels with dosing instructions for children as young as age 2 years, because no antitussive containing hydrocodone has been established as safe and effective for children younger than age 6 years. Other unapproved hydrocodone products have omitted important safety warnings and other information on their labeling, according to the FDA.

Hydrocodone-containing products have potential for adverse events such as psychotic behavior and drug abuse; nausea, vomiting, and constipation; cardiac arrest and respiratory depression; hypersensitivity, including pruritus, dermatitis, and pharyngeal edema; and intentional and unintentional overdose, according to the FDA.

More than 400 spontaneous reports of serious adverse events associated with antitussives containing hydrocodone have been reported to the FDA's voluntary MedWatch program since 2005, including deaths due to overdose, although the agency cannot separate out those pertaining to unapproved versus approved products, Dr. Jason Woo, associate director of medical and scientific affairs at the FDA's Office of Compliance, said during the teleconference.

The agency also has had reports of medication errors associated with formulation changes of unapproved hydrocodone-containing antitussives, such as changing the strength of the active ingredient, and reports of confusion over the similarity between the trade names of these unapproved products and other drug products.

“The mix-ups are a particular concern with these products. These products might be confused with one another, leading to dosing problems,” said Ms. Autor, director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research. “For example, in our NDC [National Drug Code] Directory … there are drugs named Histex and drugs named Histinex, and there are also drugs names Histuss HC, Histussin D, and Histussin HC.”

Before the FDA approves a trade name for a drug, agency researchers “make sure that we have done everything to prevent … names that sound alike or look alike or might be written alike. When a drug evades the FDA approval process, that entire process is not brought to bear,” she added. These similarly named products can contain different ingredients, so that a physician could write a prescription for a product containing one set of ingredients but actually get a similarly named product with different ingredients, Ms. Autor said.

Companies marketing unapproved hydrocodone-containing products that are labeled for use in children younger than age 6 years were required to end manufacturing and distribution of the products by Oct. 31. Marketers of other unapproved hydrocodone-containing products must stop manufacturing them by Dec. 31 and cease further shipment by March 31, 2008.

WASHINGTON — The few studies that have examined the effectiveness of incentivized pay-for-performance programs have found a mix of moderate to no improvement in quality measures, Dr. Daniel B. Mark said at the annual meeting of the Heart Failure Society of America.

There are more than 100 incentive programs in the private U.S. health care sector under the control of employer groups or managed care organizations, but congressionally authorized programs by the Centers for Medicare and Medicaid Services get the most attention, said Dr. Mark, director of the Outcomes Research and Assessment Group at the Duke (University) Clinical Research Institute, Durham, N.C.

During the last 20 years, incentivized performance programs have shown that “what you measure generally improves and what gets measured is generally what's easiest to measure. But the ease of measurement does not necessarily define the importance of the measurement.” Furthermore, little is known about whether these initiatives are cost effective for the health care system at large, Dr. Mark said, though he conceded that may be an oversimplification.

A systematic overview of 17 studies published between 1980–2005 on pay-for-performance programs found that 1 of 2 studies on system-level incentives had a positive result in which all performance measures improved. In nine studies of incentive programs aimed at the provider group level, seven had partially positive or fully positive results but had “quite small” effect sizes. Positive or partially-positive results were seen in five of six programs at the physician level (Ann. Int. Med. 2006;145:265–72).

Nine of the studies were randomized and controlled, but eight had a sample size of fewer than 100 physicians or groups; the other had fewer than 200 groups. “If these had been clinical trials, they would have all been considered extremely underpowered and preliminary,” Dr. Mark said.

Programs in four studies created unintended consequences, including “gaming the baseline level of illness,” avoiding sicker patients, and an improvement in documentation in immunization studies without any actual change in the number of immunizations given or effect on care. The studies did not include any information on the optimal duration of these programs or whether or not their effect persisted after the program was terminated. Only one study had a preliminary examination of the cost-effectiveness of a program.

Another study compared patients with acute non-ST-elevation myocardial infarction in 57 hospitals that participated in CMs' Hospital Quality Incentive Demonstration and 113 control hospitals to determine if a pay-for-performance strategy produced better quality of care. There was “very little evidence that there was any intervention effect,” said Dr. Mark. Measures not incentivized by CMS also did not appear to change (JAMA 2007;297:2373–80).

In the United Kingdom, family practice physicians participated in a pay-for-performance program in 2004 that focused on 146 quality indicators for 10 chronic diseases as well as measures related to the organization of care and the patient's experience. The National Health Service substantially increased its deficit that year because the approximately $3.2 billion that was allocated for the project was eaten by greater than predicted success in achieving the quality indicators (83% achieved vs. an expected 75%). This led to an average increase in the physicians' pay of about $40,000 that year (N. Engl. J. Med. 2006;355:375–84).

Other investigators noted that in the 1998–2003 period prior to the NHS project all of the quality indicators had already been improving, “so it's not clear how much the program's achievements can actually be attributed to the program itself,” he said (N. Engl. J. Med. 2007;357:181–90). And it is not clear what effect the program had on other conditions that were not a part of the incentive program. In any case, the U.K. government has significantly tightened up its requirements for earning extra money in the program in 2008, according to Dr. Mark.

Another study showed public reporting of quality measures alone could improve a set of quality indicators on heart failure and acute myocardial infarction by the same magnitude as a pay-for performance program that included public reporting (N. Engl. J. Med. 2007;356:486–96).

WASHINGTON — The few studies that have examined the effectiveness of incentivized pay-for-performance programs have found a mix of moderate to no improvement in quality measures, Dr. Daniel B. Mark said at the annual meeting of the Heart Failure Society of America.

There are more than 100 incentive programs in the private U.S. health care sector under the control of employer groups or managed care organizations, but congressionally authorized programs by the Centers for Medicare and Medicaid Services get the most attention, said Dr. Mark, director of the Outcomes Research and Assessment Group at the Duke (University) Clinical Research Institute, Durham, N.C.

During the last 20 years, incentivized performance programs have shown that “what you measure generally improves and what gets measured is generally what's easiest to measure. But the ease of measurement does not necessarily define the importance of the measurement.” Furthermore, little is known about whether these initiatives are cost effective for the health care system at large, Dr. Mark said, though he conceded that may be an oversimplification.

A systematic overview of 17 studies published between 1980–2005 on pay-for-performance programs found that 1 of 2 studies on system-level incentives had a positive result in which all performance measures improved. In nine studies of incentive programs aimed at the provider group level, seven had partially positive or fully positive results but had “quite small” effect sizes. Positive or partially-positive results were seen in five of six programs at the physician level (Ann. Int. Med. 2006;145:265–72).

Nine of the studies were randomized and controlled, but eight had a sample size of fewer than 100 physicians or groups; the other had fewer than 200 groups. “If these had been clinical trials, they would have all been considered extremely underpowered and preliminary,” Dr. Mark said.

Programs in four studies created unintended consequences, including “gaming the baseline level of illness,” avoiding sicker patients, and an improvement in documentation in immunization studies without any actual change in the number of immunizations given or effect on care. The studies did not include any information on the optimal duration of these programs or whether or not their effect persisted after the program was terminated. Only one study had a preliminary examination of the cost-effectiveness of a program.

Another study compared patients with acute non-ST-elevation myocardial infarction in 57 hospitals that participated in CMs' Hospital Quality Incentive Demonstration and 113 control hospitals to determine if a pay-for-performance strategy produced better quality of care. There was “very little evidence that there was any intervention effect,” said Dr. Mark. Measures not incentivized by CMS also did not appear to change (JAMA 2007;297:2373–80).

In the United Kingdom, family practice physicians participated in a pay-for-performance program in 2004 that focused on 146 quality indicators for 10 chronic diseases as well as measures related to the organization of care and the patient's experience. The National Health Service substantially increased its deficit that year because the approximately $3.2 billion that was allocated for the project was eaten by greater than predicted success in achieving the quality indicators (83% achieved vs. an expected 75%). This led to an average increase in the physicians' pay of about $40,000 that year (N. Engl. J. Med. 2006;355:375–84).

Other investigators noted that in the 1998–2003 period prior to the NHS project all of the quality indicators had already been improving, “so it's not clear how much the program's achievements can actually be attributed to the program itself,” he said (N. Engl. J. Med. 2007;357:181–90). And it is not clear what effect the program had on other conditions that were not a part of the incentive program. In any case, the U.K. government has significantly tightened up its requirements for earning extra money in the program in 2008, according to Dr. Mark.

Another study showed public reporting of quality measures alone could improve a set of quality indicators on heart failure and acute myocardial infarction by the same magnitude as a pay-for performance program that included public reporting (N. Engl. J. Med. 2007;356:486–96).

WASHINGTON — The few studies that have examined the effectiveness of incentivized pay-for-performance programs have found a mix of moderate to no improvement in quality measures, Dr. Daniel B. Mark said at the annual meeting of the Heart Failure Society of America.

There are more than 100 incentive programs in the private U.S. health care sector under the control of employer groups or managed care organizations, but congressionally authorized programs by the Centers for Medicare and Medicaid Services get the most attention, said Dr. Mark, director of the Outcomes Research and Assessment Group at the Duke (University) Clinical Research Institute, Durham, N.C.

During the last 20 years, incentivized performance programs have shown that “what you measure generally improves and what gets measured is generally what's easiest to measure. But the ease of measurement does not necessarily define the importance of the measurement.” Furthermore, little is known about whether these initiatives are cost effective for the health care system at large, Dr. Mark said, though he conceded that may be an oversimplification.

A systematic overview of 17 studies published between 1980–2005 on pay-for-performance programs found that 1 of 2 studies on system-level incentives had a positive result in which all performance measures improved. In nine studies of incentive programs aimed at the provider group level, seven had partially positive or fully positive results but had “quite small” effect sizes. Positive or partially-positive results were seen in five of six programs at the physician level (Ann. Int. Med. 2006;145:265–72).

Nine of the studies were randomized and controlled, but eight had a sample size of fewer than 100 physicians or groups; the other had fewer than 200 groups. “If these had been clinical trials, they would have all been considered extremely underpowered and preliminary,” Dr. Mark said.

Programs in four studies created unintended consequences, including “gaming the baseline level of illness,” avoiding sicker patients, and an improvement in documentation in immunization studies without any actual change in the number of immunizations given or effect on care. The studies did not include any information on the optimal duration of these programs or whether or not their effect persisted after the program was terminated. Only one study had a preliminary examination of the cost-effectiveness of a program.

Another study compared patients with acute non-ST-elevation myocardial infarction in 57 hospitals that participated in CMs' Hospital Quality Incentive Demonstration and 113 control hospitals to determine if a pay-for-performance strategy produced better quality of care. There was “very little evidence that there was any intervention effect,” said Dr. Mark. Measures not incentivized by CMS also did not appear to change (JAMA 2007;297:2373–80).

In the United Kingdom, family practice physicians participated in a pay-for-performance program in 2004 that focused on 146 quality indicators for 10 chronic diseases as well as measures related to the organization of care and the patient's experience. The National Health Service substantially increased its deficit that year because the approximately $3.2 billion that was allocated for the project was eaten by greater than predicted success in achieving the quality indicators (83% achieved vs. an expected 75%). This led to an average increase in the physicians' pay of about $40,000 that year (N. Engl. J. Med. 2006;355:375–84).

Other investigators noted that in the 1998–2003 period prior to the NHS project all of the quality indicators had already been improving, “so it's not clear how much the program's achievements can actually be attributed to the program itself,” he said (N. Engl. J. Med. 2007;357:181–90). And it is not clear what effect the program had on other conditions that were not a part of the incentive program. In any case, the U.K. government has significantly tightened up its requirements for earning extra money in the program in 2008, according to Dr. Mark.

Another study showed public reporting of quality measures alone could improve a set of quality indicators on heart failure and acute myocardial infarction by the same magnitude as a pay-for performance program that included public reporting (N. Engl. J. Med. 2007;356:486–96).

Treatment with rosuvastatin in older patients with moderate to severe chronic ischemic heart failure due to left ventricular systolic dysfunction did not reduce the risk of death from cardiovascular causes or the rate of nonfatal myocardial infarctions and stroke in the randomized Controlled Rosuvastatin Multinational Trial in Heart Failure (CORONA) presented at the annual scientific sessions of the American Heart Association.

Data from studies of statin use in patients with ischemic or nonischemic heart failure have suggested the use of statins is associated with better outcomes and beneficial effects on left ventricular function and clinical status, said the CORONA investigators.

“Doctors took for granted that statins should work in everyone with coronary artery disease,” including those with heart failure, even though there had been no placebo-controlled trial of statins in heart failure patients, said Dr. Åke Hjalmarson, at a news conference at the meeting. The results were published concurrently with the news conference in the New England Journal of Medicine (N. Engl. J. Med. 2007 Nov. 5 [Epub doi:10.1056/NEJMoa0706201]).

But the reportedly low rates of myocardial infarctions in patients with ischemic heart failure (despite having high rates of coronary artery disease), as well as possible adverse effects of the drugs, have called the use of statins in these patients into question, reported Dr. Hjalmarson of the University of Oslo, and his coinvestigators.

They were concerned with possible adverse effects of rosuvastatin on the function of skeletal and cardiac muscle, the kidneys, and the liver, but found muscle-related symptoms and elevations in creatine kinase and alanine aminotransferase levels occurred at similar rates between the rosuvastatin and placebo groups. The drug also did not further reduce LDL cholesterol in patients with already low levels.

These factors suggest “clinicians should continue [prescribing] statins for patients with ischemic heart failure and left ventricu-lar systolic dysfunction,” said Dr. Masoudi.

The patients had a mean age of 73 years and for entry into the study, had to be at least 60 years old, have chronic heart failure due to ischemia with a New York Heart Association class of II-IV, and an ejection fraction no more than 40% (no more than 35% in class II patients); the investigators also had to think that a patient did not need treatment with a cholesterol-lowering drug.

At the end of the trial's median follow-up time of nearly 33 months, there was an 8% relative reduction in the primary outcome—a composite of death from cardiovascular causes, nonfatal myocardial infarction, and nonfatal stroke—in the treated patients, a nonsignificant difference. In the 2,514 patients treated with 10 mg/day rosuvastatin, 692 reached the primary end point, compared with 732 of the 2,497 patients who received placebo. The event rates (number of events per 100 patient-years of follow-up) were 11.4 and 12.3 for the treated and placebo patients, respectively. This effect was consistent across a range of different subgroups of patients.

In a post hoc analysis, rosuvastatin significantly reduced the total number of fatal and nonfatal myocardial infarction and stroke events, compared with placebo (227 vs. 264). For rosuvastatin-treated patients, this translated into a 16% lower relative risk than placebo-treated patients. The drug had no significant effect on cardiovascular mortality, which accounted for 68% of all events in the primary composite outcome, said Dr. Hjalmarson, professor of cardiology at the Wallenberg Laboratory for Cardiovascular Research at Sahlgrenska University Hospital, Göteborg, Sweden. “The major etiology of cardiovascular deaths … may be a primary electrical event relating more to ventricular dilatation and scarring and not to a new atherothrombotic event.” Many of the researchers reported getting consulting, advisory board, and/or lecture fees from AstraZeneca, which funded the study and makes rosuvastatin.

Treatment with rosuvastatin in older patients with moderate to severe chronic ischemic heart failure due to left ventricular systolic dysfunction did not reduce the risk of death from cardiovascular causes or the rate of nonfatal myocardial infarctions and stroke in the randomized Controlled Rosuvastatin Multinational Trial in Heart Failure (CORONA) presented at the annual scientific sessions of the American Heart Association.

Data from studies of statin use in patients with ischemic or nonischemic heart failure have suggested the use of statins is associated with better outcomes and beneficial effects on left ventricular function and clinical status, said the CORONA investigators.

“Doctors took for granted that statins should work in everyone with coronary artery disease,” including those with heart failure, even though there had been no placebo-controlled trial of statins in heart failure patients, said Dr. Åke Hjalmarson, at a news conference at the meeting. The results were published concurrently with the news conference in the New England Journal of Medicine (N. Engl. J. Med. 2007 Nov. 5 [Epub doi:10.1056/NEJMoa0706201]).

But the reportedly low rates of myocardial infarctions in patients with ischemic heart failure (despite having high rates of coronary artery disease), as well as possible adverse effects of the drugs, have called the use of statins in these patients into question, reported Dr. Hjalmarson of the University of Oslo, and his coinvestigators.

They were concerned with possible adverse effects of rosuvastatin on the function of skeletal and cardiac muscle, the kidneys, and the liver, but found muscle-related symptoms and elevations in creatine kinase and alanine aminotransferase levels occurred at similar rates between the rosuvastatin and placebo groups. The drug also did not further reduce LDL cholesterol in patients with already low levels.

These factors suggest “clinicians should continue [prescribing] statins for patients with ischemic heart failure and left ventricu-lar systolic dysfunction,” said Dr. Masoudi.

The patients had a mean age of 73 years and for entry into the study, had to be at least 60 years old, have chronic heart failure due to ischemia with a New York Heart Association class of II-IV, and an ejection fraction no more than 40% (no more than 35% in class II patients); the investigators also had to think that a patient did not need treatment with a cholesterol-lowering drug.

At the end of the trial's median follow-up time of nearly 33 months, there was an 8% relative reduction in the primary outcome—a composite of death from cardiovascular causes, nonfatal myocardial infarction, and nonfatal stroke—in the treated patients, a nonsignificant difference. In the 2,514 patients treated with 10 mg/day rosuvastatin, 692 reached the primary end point, compared with 732 of the 2,497 patients who received placebo. The event rates (number of events per 100 patient-years of follow-up) were 11.4 and 12.3 for the treated and placebo patients, respectively. This effect was consistent across a range of different subgroups of patients.

In a post hoc analysis, rosuvastatin significantly reduced the total number of fatal and nonfatal myocardial infarction and stroke events, compared with placebo (227 vs. 264). For rosuvastatin-treated patients, this translated into a 16% lower relative risk than placebo-treated patients. The drug had no significant effect on cardiovascular mortality, which accounted for 68% of all events in the primary composite outcome, said Dr. Hjalmarson, professor of cardiology at the Wallenberg Laboratory for Cardiovascular Research at Sahlgrenska University Hospital, Göteborg, Sweden. “The major etiology of cardiovascular deaths … may be a primary electrical event relating more to ventricular dilatation and scarring and not to a new atherothrombotic event.” Many of the researchers reported getting consulting, advisory board, and/or lecture fees from AstraZeneca, which funded the study and makes rosuvastatin.

Treatment with rosuvastatin in older patients with moderate to severe chronic ischemic heart failure due to left ventricular systolic dysfunction did not reduce the risk of death from cardiovascular causes or the rate of nonfatal myocardial infarctions and stroke in the randomized Controlled Rosuvastatin Multinational Trial in Heart Failure (CORONA) presented at the annual scientific sessions of the American Heart Association.

Data from studies of statin use in patients with ischemic or nonischemic heart failure have suggested the use of statins is associated with better outcomes and beneficial effects on left ventricular function and clinical status, said the CORONA investigators.

“Doctors took for granted that statins should work in everyone with coronary artery disease,” including those with heart failure, even though there had been no placebo-controlled trial of statins in heart failure patients, said Dr. Åke Hjalmarson, at a news conference at the meeting. The results were published concurrently with the news conference in the New England Journal of Medicine (N. Engl. J. Med. 2007 Nov. 5 [Epub doi:10.1056/NEJMoa0706201]).

But the reportedly low rates of myocardial infarctions in patients with ischemic heart failure (despite having high rates of coronary artery disease), as well as possible adverse effects of the drugs, have called the use of statins in these patients into question, reported Dr. Hjalmarson of the University of Oslo, and his coinvestigators.

They were concerned with possible adverse effects of rosuvastatin on the function of skeletal and cardiac muscle, the kidneys, and the liver, but found muscle-related symptoms and elevations in creatine kinase and alanine aminotransferase levels occurred at similar rates between the rosuvastatin and placebo groups. The drug also did not further reduce LDL cholesterol in patients with already low levels.

These factors suggest “clinicians should continue [prescribing] statins for patients with ischemic heart failure and left ventricu-lar systolic dysfunction,” said Dr. Masoudi.

The patients had a mean age of 73 years and for entry into the study, had to be at least 60 years old, have chronic heart failure due to ischemia with a New York Heart Association class of II-IV, and an ejection fraction no more than 40% (no more than 35% in class II patients); the investigators also had to think that a patient did not need treatment with a cholesterol-lowering drug.

At the end of the trial's median follow-up time of nearly 33 months, there was an 8% relative reduction in the primary outcome—a composite of death from cardiovascular causes, nonfatal myocardial infarction, and nonfatal stroke—in the treated patients, a nonsignificant difference. In the 2,514 patients treated with 10 mg/day rosuvastatin, 692 reached the primary end point, compared with 732 of the 2,497 patients who received placebo. The event rates (number of events per 100 patient-years of follow-up) were 11.4 and 12.3 for the treated and placebo patients, respectively. This effect was consistent across a range of different subgroups of patients.

In a post hoc analysis, rosuvastatin significantly reduced the total number of fatal and nonfatal myocardial infarction and stroke events, compared with placebo (227 vs. 264). For rosuvastatin-treated patients, this translated into a 16% lower relative risk than placebo-treated patients. The drug had no significant effect on cardiovascular mortality, which accounted for 68% of all events in the primary composite outcome, said Dr. Hjalmarson, professor of cardiology at the Wallenberg Laboratory for Cardiovascular Research at Sahlgrenska University Hospital, Göteborg, Sweden. “The major etiology of cardiovascular deaths … may be a primary electrical event relating more to ventricular dilatation and scarring and not to a new atherothrombotic event.” Many of the researchers reported getting consulting, advisory board, and/or lecture fees from AstraZeneca, which funded the study and makes rosuvastatin.